San Francisco/Bay Area Chapter

The San Francisco / Bay Area Chapter was founded in 1991 and has emerged to be the leading non-profit guild in the Bay Area. Membership is made up of biotechnology, pharmaceutical, and medical device manufacturers, research organizations, architects/engineers/consultants, construction firms, government agencies, academic institutions, equipment manufacturers, and suppliers.

Global News

07 December, 2023
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iSpeak Blog

ATMP Cleanroom Facilities: A Roadmap for Success

What is the Route to Successful ATMP Cleanroom Development? Mitch Gonzales, Vice President of Process Technology and Grant Merrill, Chief Commercial Officer at AES Clean...

06 December, 2023
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iSpeak Blog

Preparing our Teams for the Facilities of the Future

The ISPE Facility of the Future Conferences can feel like a crystal ball looking into the future . Year after year, speakers have presented what the future of the industry may...

05 December, 2023
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iSpeak Blog

Pharma 4.0 Enabling Technologies: Use Cases, Benefits and Constraints

At the 2023 ISPE Pharma 4.0™ & Annex 1 Conference in Barcelona, Spain and virtual, Track #6 will focus on Pharma 4.0 Enabling Technologies: Use Cases, Benefits, and...
Global Events

Pharmaceutical Water Systems (T35)

12 December, 2023

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Classroom Training

Pharmaceutical Water Systems

This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis...

Science and Risk-based C&Q (T40)

06 February, 2024

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Classroom Training

Commissioning and Qualification Training Course

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)...

GAMP® Data Integrity 21 CFR Part 11 (T50)

06 February, 2024

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Classroom Training

GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course

This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...
Videos

1 December 2023
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Video

Highlights: 2023 ISPE Annual Meeting & Expo

Thank you to all those who attended the 2023 ISPE Annual Meeting & Expo, and a big thank you to the sponsors for making this conference possible, and the program committee for curating an in-depth and interactive...

26 October 2023
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Video

Congratulations to the 2023 ISPE Facility of the Year Award Winners

ISPE unveiled the prestigious 2023 Facility of the Year Award (FOYA) Overall Winner recipient during the FOYA Celebratory Reception and Banquet at the 2023 ISPE Annual Meeting & Expo. The event showcased the overall...

6 October 2023
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Video

2023 Category Winners for Social Impact: Takeda

Takeda is a global values-based, R&D-driven biopharmaceutical leader committed to creating better health for people and a brighter future for the world. For more than 240 years, Takeda has focused on delivering...

Design Considerations for Large-Scale Stem Cell Manufacturing

Pharmaceutical Engineering Magazine

There is much that large-scale commercial stem cell therapy processes can adopt from the existing bioprocessing industry. This article addresses some of the unique challenges posed by large-scale stem cell and stem cell–derived product manufacturing...

Read Full Article

View Current Issue

San Francisco/Bay Area Chapter

San Francisco/Bay Area Chapter

ATMP Cleanroom Facilities: A Roadmap for Success

Preparing our Teams for the Facilities of the Future

Pharma 4.0 Enabling Technologies: Use Cases, Benefits and Constraints

Highlights: 2023 ISPE Annual Meeting & Expo

Congratulations to the 2023 ISPE Facility of the Year Award Winners

2023 Category Winners for Social Impact: Takeda

Design Considerations for Large-Scale Stem Cell Manufacturing

Recent Updates

ATMP Cleanroom Facilities: A Roadmap for Success

Making Sense of Engineering Titles in Biopharma

Preparing our Teams for the Facilities of the Future

Pharma 4.0 Enabling Technologies: Use Cases, Benefits and Constraints

Manufacturing and Supply Chain: Making Space Between a Rock and a Hard Place

ISPE Global Regulatory Townhall Focused on Review and Inspection Practices